FDA recall D-0813-2026

Product

CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10.

Reason for recall

CGMP Deviations

Distribution

US Nationwide; Puerto Rico; and Chile.

Key facts

Status

Ongoing

Initiation date

2026-08-06

Report date

2026-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0813-2026